ACTRN12614000460606已完成未知
A randomised single blinded cross over trial to investigate the effect of Zespri green kiwifruit on digestive and gut health function in healthy participants and individuals with irritable bowel syndrome (constipation).
Zespri International0 个研究点目标入组 60 人开始时间: 2014年5月2日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Healthy group: Adult (18-65 years); BMI 18-35; Generally healthy; Normal bowel habits
- •Functionally constipated group: 1.Adult (18-65 years); Females will be required to declare stage of menstrual cycle during the different trial phases; BMI between 18-35; Presence of functional constipation according to ROME III diagnostic criteria for functional constipation.
- •IBS-C group: 1.Adult (18-65 years); Females will be required to declare stage of menstrual cycle during the different trial phases; BMI between 18-35; Presence of functional constipation according to ROME III diagnostic criteria for IBSC.
排除标准
- •Individuals with alarm features associated with bowel habit (recent changes in bowel habit (<3 months), rectal bleeding, weight loss, occult blood in stools, anaemia) , anal fissures, bleeding haemorrhoids, and family history of GI cancer or IBD.
- •Chronic disease (cardiovascular, cancer, renal failure, previous gastrointestinal surgery (not including appendectomy or cholecystectomy), neurological conditions (e.g. multiple sclerosis, spinal chord injury, stroke).
- •All patients will be screened at recruitment for fasting blood glucose. Those with results greater than 7.2 mmol/l will not be accepted into the trial.
- •Participants with diagnosed and stable conditions requiring the use of SSRI’s (selective serotonin reuptake inhibitors), tricyclates, opiates or anti-inflammatories will be permitted into the trial on condition the medication has been in use continually and the condition has been stable for > 3 months. Similarly those with stable and controlled diabetes (> 3 months) will be permitted to participate.
- •Women who are pregnant, breastfeeding or planning a pregnancy in the 3 months post selection (trial period) will be excluded.
- •Potential participants with known kiwifruit or latex allergy will be excluded.
- •Potential participants using laxatives who are not prepared to stop using the laxatives for the 2 week lead-in period will be excluded.
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